Efficacy and Safety Study of ME-609 and Acyclovir for Treatment of Herpes Simplex Labialis
This study has been completed.
Sponsor:
Medivir
Collaborator:
-
Information provided by:
Medivir
ClinicalTrials.gov Identifier:
NCT00361881
First received: August 8, 2006
Last updated: August 14, 2008
Last verified: August 2008
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Purpose
The purpose of this study is to determine whether ME-609 is more efficient than acyclovir and placebo for the treatment of recurrent herpes labialis.
| Condition | Intervention | Phase |
|---|---|---|
|
Herpes Labialis |
Drug: ME-609 Drug: acyclovir in ME-609 vehicle Drug: Vehicle |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Prevention |
| Official Title: | A Randomized, Double-Blind, Active Controlled, Vehicle-Controlled, Subject Initiated Study Comparing Efficacy and Safety of ME-609 Versus Acyclovir Cream for Treatment of Recurrent Herpes Simplex Labialis |
Resource links provided by NLM:
Further study details as provided by Medivir:
Primary Outcome Measures:
- Proportion of subjects with non-ulcerative recurrences measured as the proportion of subjects in whom the study recurrence did not progress beyond the papule stage. [ Time Frame: 5 days ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Episode duration [ Time Frame: until healing ] [ Designated as safety issue: No ]
| Enrollment: | 1443 |
| Study Start Date: | July 2006 |
| Study Completion Date: | December 2007 |
| Primary Completion Date: | August 2007 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: 1
ME-609
|
Drug: ME-609
Cream, dose 5 times daily during 5 days.
|
|
Active Comparator: 2
Acyclovir in ME-609 vehicle
|
Drug: acyclovir in ME-609 vehicle
Dose 5 times daily for 5 days
|
|
Placebo Comparator: 3
Vehicle
|
Drug: Vehicle
Dose 5 times daily for 5 days
|
Detailed Description:
This was a randomized, double-blind, active- and vehicle-controlled study comparing the effects of ME-609, acyclovir in ME-609 vehicle, and vehicle alone. Treatment was subject-initiated within 1 hour of experiencing the first signs or symptoms of a herpes recurrence. The subject visited a study clinic as soon as possible after treatment initiation, but no later than midnight of the following day, for evaluation.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Generally good health
- History of recurrent herpes labialis with at last three episodes during the prior 12 months
Exclusion Criteria:
- Treatment with antivirals or immunosuppressive agents within 2 weeks prior to randomization
- Pregnant and/or nursing women
- Continuous daily treatment with pain medication
- Significant skin condition that occur in the area of herpes recurrences
Contacts and Locations More Information
No publications provided by Medivir
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Börje Darpö, MD, PhD, Medivir AB |
| ClinicalTrials.gov Identifier: | NCT00361881 History of Changes |
| Other Study ID Numbers: | 609-04 |
| Study First Received: | August 8, 2006 |
| Last Updated: | August 14, 2008 |
| Health Authority: | United States: Food and Drug Administration |
Additional relevant MeSH terms:
|
Herpes Labialis Herpes Simplex Herpesviridae Infections DNA Virus Infections Virus Diseases Skin Diseases, Viral Lip Diseases Mouth Diseases |
Stomatognathic Diseases Skin Diseases, Infectious Skin Diseases Acyclovir Antiviral Agents Anti-Infective Agents Therapeutic Uses Pharmacologic Actions |
ClinicalTrials.gov processed this record on June 17, 2013